1. Quality Assurance Update Presented byRay Hardwick Presented by: Ray Hardwick

2. Background DNFSB Tech Report 25 (January 2000) and Tech Report 31 (March 2001) DNFSB public meetings on QA (2000 & 2001) Department begins to develop Quality Assurance Improvement Plan (QAIP) DNFSB issues Recommendation 2002-1

3. Current Status Phased approach to implementing the QA Improvement Plan (safety systems at defense nuclear facilities first) QA Improvement Plan approved by the Secretary of Energy and sent to DNFSB (November 2002) Implementation of QA Improvement Plan is ongoing Recommendation 2002-1 Implementation Plan approved by the Secretary of Energy and sent to DNFSB (March 17, 2003) EH continues to take an active role in QA coordination and integration

4. QAIP Project Plan Structure Three Levels: Goals Actions Action Execution – implementation details, schedule, Program Office responsible lead

5. Quality Assurance Improvement Plan Goals Goal 1 - Correct the weaknesses in the quality assurance program that effect safe operation of items serving vital safety functions at the Department’s defense nuclear facilities. Goal 2 – To be covered by 2002-1 Implementation Plan Goal 3 - Assure effectiveness of Quality Assurance Programs for items serving vital safety functions at the Department’s defense nuclear facilities.

6. QAIP Goal 1 Correct the weaknesses in the quality assurance program that effect safe operation of items serving vital safety functions at the Department’s defense nuclear facilities. –Analyze the results of EM and NA assessments. Request that appropriate actions be taken to address issues identified as affecting safe operation of vital safety systems. –EM and NA will provide a schedule for oversight reviews that will verify the effectiveness of actions taken to address identified issues. –Implement DOE Policy P 450.5 Line Environment, Safety and Health Oversight reviews –Review the Functions, Responsibilities and Authorities Manual (FRAM) and ensure it incorporates Federal responsibilities defined in the Quality Assurance Rule and Order, including the responsibilities for overseeing the contractor’s quality assurance program. –EM will maintain Integrated Safety Management Systems (ISMS) by approving annual revisions (DOE and Contractor) or approving basis for no annual revision, and establishing schedules for revisions and re-verifications (DOE and Contractor) to approved ISMS

7. QAIP Goal 3 Assure effectiveness of Quality Assurance Programs for items serving vital safety functions at the Department’s defense nuclear facilities. –NA will Validate that contractors are complying with 10 CFR 830.121(c)(2) regarding integrating QA (including software quality assurance) with ISMS. –NA will ensure that programs and processes are in place that provides the oversight of quality assurance programs consistent with DOE Policy P 450.5 and DOE Order O 414.1. –NA will Validate and verify that Quality Assurance Programs are effectively implemented for the design, procurement, fabrication, construction and operation of Safety Systems..

8. QAIP Goal 3 (cont.) - EM will promulgate processes and procedures for FRA and QA document requirements. - EM will establish contract change control expectations. - EM establish and implement contract change control process, including establishing performance measures and incentives. - EM and NA will ensure that DOE and Contractor Annual updates to ISMS and QA Program Descriptions are integrated and occur. - EM will integrate assessment of vital safety systems into DOE oversight and contractor self-assessment for ISMS and QA to ensure quality of design, procurement, fabrication, construction and safe operation of Safety Systems

9. DNFSB Recommendation 2002-1 Issued by the DNFSB on September 23, 2002 Accepted by the Secretary on November 21, 2002 Implementation Plan (IP) Approved by the Secretary on March 17, 2003 2002-1 Response Team Ray Hardwick (EH)Robin Henderson (GC) Dae Chung (EM)Xavier Ascanio (DP) Roger Rollins (SR)Mike Glasman (Y-12) Dave Brown (ORP)Anton Tran (AL)

10. DNFSB Recommendation 2002-1 Recommendations were made in the areas of: –Responsibility and Authority –Recommended Computer Codes for Safety Analysis –Proposed Changes to the Directives System –Research and Development

11. Recommendation 2002-1 Implementation Plan Roles and Responsibilities Computer Codes Requirements and Guidance Continuous Improvement

12. Roles and Responsibilities Issue a DOE Notice on Responsibilities and Authorities Establish SQA Technical Qualification Requirements for Federal Personnel Identify Federal SQA Positions Federal SQA Personnel Achieve Qualifications Revise the FRAM to include SQA Roles and Responsibilities Revise the FRAs to include SQA Roles and Responsibilities

13. Computer Codes Identify the Safety Analysis Toolbox Codes Establish SQA Criteria for Toolbox Codes Perform a Gap Analysis on the Toolbox Codes to Bring Them into Compliance with SQA Criteria Issue Code-Specific Guidance Reports for the Toolbox Codes Conduct a Survey of Design Codes for Toolbox Applicability Establish and Implement a Central Registry Conduct an Assessment of Safety System Software Conduct and Assessment of Safety Analysis Software

14. Requirements and Guidance Conduct a Review of Industry and Federal Agency Standards for Applicability Develop, Review and Approve new SQA Directives Review and new Directives and Determine the Actions Required to Implement

15. Continuous Improvement Establish a Corporate QA Function (including SQA) within EH Identify Methods for Capturing SQA Lessons Learned Establish Relationships and Actively Participate with Outside Organizations

16. Near-Term 2002-1 Activities Establish SQA criteria for safety analysis tool box codes and perform a gap analysis on the existing codes. Identify a Central Registry Issue a DOE Notice that identified organizational roles and responsibilities for SQA (Feds and contractors) Develop CRADs for safety analysis software and safety system software assessments. Conduct a review and industry and government agency SQA standards

17. Consolidation of QA-Related Groups in DOE EFGOC Contractor QA Mgrs QA Topical Committee Fed QA Mgrs NLIC Lab QA Mgrs QA-Related Groups QAWG? SQAS? QSM-SIG? SASG? SQIG? Etc.

18. Coordination With Other Groups and Agencies QA Topical Committee NASA ANSI GIDEP NUSMG IEEE DNFSB NRC

19. Path Forward in Quality Assurance Implement and track actions in the approved QAIP Commence Activities Identified in the Project Plan for Recommendation 2002-1 Implementation Plan Continue to work closely with Defense Board, EFCOG, NLIC and other groups to provide status and updates Consolidate and coordinate activities of DOE QA groups (QAWG, QSM SIG, SASG, EFCOG, NLIC, etc.) Clearly define the corporate role of EH with regards to quality assurance programs and processes

20. Additional Information Recommendation 2002-1 Link at the Departmental Representatives Web Page (www.deprep.org)www.deprep.org Have an Interest in Helping? –Ray Hardwick at raymond.hardwick@hq.doe.gov